PolySuture Indústria e Comércio Ltda.

Certificate Status  Valid
Certificate No EUCE1620DE67BR
Company Name PolySuture Indústria e Comércio Ltda.
Issue Date 18 July, 2021
Validity Date 17 July, 2026
Scope Surgycryl™ / Maxsorb™ Sterile Synthetic Absorbable Surgical Suture.
Supplementary Information to CE 649010

Needle and Suture Combinations from within the following limits:
Suture Characteristics and its Range:
1. Absorbable / Non-Absorbable: Absorbable
2. Suture Gauge Size: 0.5- 5.0 (Metric)
3. Suture Length: 10 cm – 250 cm
4. Suture Dyed / Undyed: Dyed / Undyed
5. Suture Color (If Dyed): Violet
6. Coated / Uncoated: Uncoated
7. Multifilament / Monofilament: Monofilament
8. Accessories of Suture: N/A
9. Needled / Non-Needled: Needled
10. Number of Needles per Suture: 1 – 2
11. Needle Material: Stainless Steel
12. Needle Coating: Silicon (when applicable)
13. Needle Type: Taper Point, Tapercut, Reverse Cutting, Blunt Point, Spatula, Taper Point and Square Body
14. Needle Shape: Straight, 3/8 Circle, 1/2 Circle, 5/8 Circle, 1/6 Circle, 1/4 Circle.
15. Needle Length: 9.0 mm – 7.0 cm
16. Needle Diameter: 0.140mm – 1.570 mm

Certificate Type CE – (EU) Directive 93/42/EEC on Medical Devices